Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name electrode, electrosurgical
510(k) Number K882421
Device Name INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE
Applicant
DERMACARE PRODUCTS, INC.
7651 NATIONAL TURNPIKE
LOUISVILLE,  KT  40214
Applicant Contact KEN POTTS
Correspondent
DERMACARE PRODUCTS, INC.
7651 NATIONAL TURNPIKE
LOUISVILLE,  KT  40214
Correspondent Contact KEN POTTS
Regulation Number878.4400
Classification Product Code
JOS  
Date Received06/13/1988
Decision Date 06/30/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-